Kornimate/medical-research-clean huggingface dataset:
the benefit of local anesthesia at the sternum in patients with coronary surgery

Conditions: Coronary Bypass Graft Stenosis

Summary: patients undergoing coronary artery bypass grafting are at risk for perioperative myocardial ischemia. episodes of tachycardia and hypertension, which are associated with an increase in myocardial oxygen consumption, are predictive events of these ischemia. during cardiac surgery by sternotomy, some maneuvers, e.g. intubation, skin incision, sternotomy and cannulation, may be associated with tachycardia and/or increases in blood pressure despite an adequate level of anesthesia. usually these episodes are controlled by the administration of a high-dose of anesthetic agents. the parasternal block, by bolus or continuous infusion through a single catheter, showed its effectiveness on postoperative pain after sternotomy. it allows a blocking of anterior branches of intercostal nerves at the lateral edge of the sternum; branches in charge of innervation of the sternum and the overlying skin surface. the preoperative parasternal block, once general anesthesia performed, could provide an effective level of locoregional anesthesia of the chest wall, thus limiting the occurrence of episodes of tachycardia and / or hypertension without having to resort to massive doses of anesthetic agents during sternotomy in patients undergoing coronary bypass surgery.

this randomized double blinded placebo-controlled clinical trial will include patients undergoing coronary artery bypass grafting. locoregional anesthesia of the chest wall will be performed under ultrasound, once general anesthesia performed. a total volume of 60 ml of sodium chloride 0.9% (placebo group) or ropivacaine 0.25% (experimental group) divided into 4 injections of 15 ml (2 per side, between ribs 2 and 3 and between ribs 4 and 5) will be injected.

Eligibility criteria:
inclusion criteria: * patients undergoing coronary artery bypass graft requiring sternotomy other than re-interventions and combined surgeries * consent for participation * affiliation to the french social security system exclusion criteria: * pregnant or breastfeeding women * patients under protection of the adults (guardianship, curator or safeguard of justice) * communication difficulties or neuropsychiatric disorder * neuropathic disease * constitutional coagulation disorders * kidney insufficiency * sensitivity to nonsteroidal anti-inflammatory drugs * hypersensitivity to local anaesthetics * chronic use of opioid analgesics * corticosteroid treatment or immunosuppressive therapy * autoimmune disease * chronic pain syndrome or fibromyalgia * emergency cardiac surgery * hypovolemia

Keywords: regional anesthesia sternotomy
pharmacokinetics and safety of pol7080 in patients with renal impairment

Conditions: Renal Impairment

Summary: to investigate the pharmacokinetics (pk) of pol7080 in subjects with renal function impairment after single intravenous (iv) infusion of pol7080


Eligibility criteria:
inclusion criteria: 1. subjects who signed informed consent. 2. male subjects ≥18 and ≤79 years of age; female subjects ≥18 and ≤79 years of age of non-childbearing potential 3. weight within a bmi range of 19.0-35.0 kg/m2. 4. clcr according to cockcroft gault equation of: * 50-80 ml/min (mild renal impairment) * 30- \<50 ml/min (moderate renal impairment) * \<30 ml/min (severe renal impairment) * subjects receiving dialysis for ≥3 months before dosing (esrd) * \>80 ml/min (normal renal function) exclusion criteria: 1. unwilling or unable to give informed consent. 2. as a result of the medical screening process, the study physician considers the subject unfit for the study. 3. demonstrating excess in xanthine consumption (more than 5 cups of coffee or equivalent per day). 4. subjects who smoke more than 10 cigarettes a day. 5. subjects who consume more than 28 units (males) or more than 21 units (females) of alcohol per week. 6. any history of hypersensitivity to the imp. 7. for subjects with renal impairment: no clinically significant change in disease status within at least 1 month prior to study entry, as determined by the investigator. 8. the subject had donated a unit of blood (450 ml) within the 3 months before dosing, or intends to donate in the month after the last scheduled visit. 9. participation in another clinical study with an investigational drug or device within the last month. 10. subjects with clinically significant telemetric ecg abnormalities on day -1 11. significant allergies requiring intranasal or systemic corticosteroids during any time of the year or history of any anaphylactic reaction. 12. positive test for human immunodeficiency virus (hiv) antibodies. 13. acute hepatitis b or c infection. 14. the subject has tested positive for drugs of abuse at screening. 15. subjects who have received any prescribed systemic or topical medication within 4 weeks prior to dosing (excluded are those drugs the renally impaired subject is currently taking for treatment of the renal or concomitant disease). 16. immunocompromised patients (patients after solid organ or bone marrow transplant; patients receiving immunosuppressive treatment). 17. subjects with known or suspected pseudomonas infection or colonization (e.g. patients with cystic fibrosis). 18. subjects with significant liver function abnormalities 19. subjects with acute myocardial infection or unstable angina pectoris

Keywords: pol7080 pharmacokinetics
assessment of psychological symptoms and health related quality of life in patients with irritable bowel syndrome

Conditions: IBS - Irritable Bowel Syndrome

Summary: to evaluate the relation between the clinical presentations and the psychiatric co-morbidities with the quality of life in patients with irritable bowel syndrome.

ibs is a chronic functional disorder characterized by abdominal pain and altered bowel habit in the absence of a specific and unique organic pathology. rome iv criteria is used to diagnose ibs patients which depends on the presence of recurrent abdominal pain on average at least 1 day per week in the last 3 months associated with 2 or more of the following; related to defecation, associated with change in frequency of stool , associated with change in stool form. these criteria should be fulfilled for the last 3 months with symptom onset at least 6 months before diagnosis.\]1.\[ brian et al 2017)\[ ibs sub-types include 4 sub-types described according to the dominant stool pattern diarrhea (ibs -d) , constipation (ibs- c) , mixed ( ibs-m) , unspecified( ibs-u) subtypes . \] \[2 cristiane kibune nagasako et al 2016 \[ the identified risk factors for ibs include female sex , younger age , psychological stress during or before infectious gastroenteritis , and the severity of enteritis. \[3 \] oh young lee et al 2010 ibs is a painful condition associated with significant psychological distress and psychiatric comorbidities such as higher levels of anxiety or depression and suicidal ideation, with a negative impact on quality of life \[4 \] .canavan et al., 2014; stasiet al., 2014). major psychiatric disorders seen in patients were gad and mde. gad was seen in 30.0% of patients having ibs while mde was present in 28.0% \[5\] therefore, ibs consequences are measured in direct costs; medical treatment and procedures or indirect costs such as reduced productivit and low quality of life.\[6\] doshi et al., 2014a however, few studies were conducted to evaluate the impact of clinical presentations or psychiatric co-morbidities with the quality of life in ibs.

Eligibility criteria:
inclusion criteria: * 1- patient age between 18 - 50 years old 2- patients fulfilling rome iv criteria with normal investigations such as cbc, esr , liver and kidney function and \\ or colonoscopy 3- healthy control: who do not fulfil rome iv criteria with normal investigations exclusion criteria: * 1- those older than 50 years of age with recent onset of symptoms (less than 6 months). 2- organic causes of colonic symptom. 3- patients with ibs who have alarm signs. 4- those with coexisting diseases (e.g. intestinal parasites, malignancy, diabetes mellitus cardiovascular pulmonary, hepatic, or renal disorder). 5- those with a family history of colorectal cancer. 6- ibs in children (\< 18 years) and ibd-ibs patients
subjective outcomes after acl reconstruction with bqt autograft

Conditions: ACL Injury; Knee Injuries

Summary: the purpose of the study is to compare short-term patient reported outcome measures (prom) of bone-quadriceps-tendon (bqt) autograft with semitendinosus-gracilis (stg) and bone-patellar-tendon-bone (bptb) autografts following anterior cruciate ligament reconstruction (aclr). the prom used are knee injury and osteoarthrithis outcome score (koos) and tegner. difference in change in koos, koos subscales and tegner from preoperative baseline to one-year follow-up and absolute koos, koos subscales and tegner at one-year follow-up were evaluated. all of which were bqt compared to stg and bptb, respectively. the primary outcome is change in koos from preoperative baselinge to one-year follow-up. other outcomes are secondary. the hypothesis was that patients receiving the bqt autograft show similar results in koos, koos subscales and tegner as patients receiving stg or bptb autografts.


Eligibility criteria:
inclusion criteria: - exclusion criteria: * revision acl surgery * multiligament surgery * nonresponders in prom at preoperative baseline or one-year follow-up
developing an eeg probe for studying and modulating cognitive control

Conditions: Post-stroke Depression

Summary: this study aims to investigate effects of transcranial current stimulation (tes) and transcutaneous direct current stimulation (tsdcs) associated changes on fronto-parietal eeg and cognitive performance in patients with post stroke depression (psd)

the investigators will perform a double blind, randomized, sham controlled, crossover study design to assess effects of tes, tsdcs and sham stimulation on the performance during a cognitive control task. the working hypothesis is tsdcs and/or tes will enhance frontal theta oscillations as recorded on eegs and improve task performance compared to sham stimulation. results from this project can potentially lead to the development of a new research tool for assessing neuromodulation strategies to treat mental disorders and their comorbidities. it will also uncover the neural correlates of cognitive deficits in psd and provide feasible biomarkers associated with treatment response in support of a larger clinical.

Eligibility criteria:
inclusion criteria: 1. subjects will include both male and female of age over 18 years and a bmi of 18-35 kg/mts2 who have experienced stroke. 2. moderately depressed, madrs:18-28, phq9: 10-20 and/or experiencing cognitive impairments after stroke exclusion criteria: 1. current or lifetime bipolar disorder or schizophrenia diagnosis; 2. current (past month): ptsd, psychotic or substance use disorder (nicotine and caffeine allowed); 3. significant risk of suicide according to cssrs or clinical judgment, or suicidal behavior in the past year: 4. current chronic severe pain conditions; 5. current chronic use of: opioids analgesics, medications that affect blood pressure or drugs with significant autonomic effects (stimulants and antipsychotics allowed if dose stable for 1 month); 6. skin lesions on electrode placement region; 7. implanted electrical medical devices; 8. pregnancy; 9. suspected iq\<80, and 10) any other clinically relevant reason as judged by the clinician.
a study of amifostine for prevention of facial numbness in radiosurgery treatment of trigeminal neuralgia

Conditions: Trigeminal Neuralgia

Summary: trigeminal neuralgia or tic douloureux is severe, often debilitating, facial pain that significantly impairs the patient's quality of life and health. stereotactic radiosurgery has been shown to provide pain relief in majority of patients treated. however, a common side effect of radiosurgery is facial numbness. our goal is to maximize pain control while minimizing side effects. to this end, the purpose of this study is to evaluate whether adding a drug, amifostine, at the time of radiosurgery will protect patients from facial numbness.

patients will be evaluated by a multi-disciplinary team composed of radiation oncologists and neurosurgeons. pretreatment pain, neurologic function (including facial numbness), and health related quality of life will be assessed. patients will be treated in a single session with 75 gy maximal dose covering a 6 mm segment of the retrogasserian cisternal portion of the trigeminal sensory root. treatment will be delivered using the cyberknife robotic radiosurgery system with the patient in the supine position. an aquaplast head mask will be used to ensure adequate immobilization during therapy. the target volume shall be the 6 mm segment of the retrogasserian cisternal portion of the trigeminal sensory root. patients will receive subcutaneous injection of amifostine (500 mg) or placebo 30 minutes +/- 30 minutes prior to srs. facial pain will be assessed using the visual analog scale and short-form mcgill pain questionnaire. following srs, patients will be followed at 1, 3, 6, and 9 months ±7 days. facial numbness will be assessed using the barrow neurologic institute (bni) facial numbness score. patient reported bni facial numbness scoring and complete cranial nerve exam by a physician will be performed pre-treatment and at follow-up visits.

Eligibility criteria:
inclusion criteria: all patients age 18 years and older with typical trigeminal neuralgia, as determined by diagnostic criteria set by the international headache society, who are: * intolerant of or refractory to medical management; and * not candidates for or refusing a surgical micro-vascular decompression. exclusion criteria: * patients who present with pre-existing bni grade iii or iv facial numbness. * patients who have previously been treated with mvd. * patients who have previously had an ablative treatment, including prior srs. * pediatric patients (age \<18), pregnant women, and patients who are unable to give informed consent will be excluded.

Keywords: tic douloureux
impact of preoperative serum albumin level on postoperative outcomes in chinese hcc patients treated with surgery

Conditions: Hepatocellular Carcinoma

Summary: this is an observational and retrospective cohort study to evaluate the impact of the preoperative serum albumin concentration on postoperative outcomes among hepatocellular carcinoma (hcc) patients who received hepatectomy or liver transplantation.

the impact of hypoalbuminemia on postoperative outcomes has been the subject of several investigations which agreed that hypoalbuminemia is an important risk factor for mortality and morbidity after various types of surgical operations. unfortunately, there are limited real-world data to establish the correlation between hypoalbuminemia and hepatectomy or liver transplantation postoperative complications in china. this study will evaluate the impact of the preoperative serum albumin concentration on postoperative outcomes among hepatocellular carcinoma (hcc) patients who received hepatectomy or liver transplantation.

Eligibility criteria:
inclusion criteria: * patients who diagnosed with hcc confirmed by histology/cytology or clinically criteria regardless of gender. * hcc patients who had received the first hepatectomy or liver transplantation (lt). * age ≥18 years at the start date of the hepatectomy or lt. * hcc patients who had the value of serum albumin within 7 days prior to the surgery. * hcc patients who had exemption of informed consent. exclusion criteria: * hcc patients with extrahepatic metastasis or other malignant tumours.

Keywords: hepatocellular carcinoma albumin hepatectomy liver transplantation postoperative outcomes
incidence and clinical characteristics of pulmonary hypertension secondary to ards in the highland

Conditions: ARDS

Summary: the study is conducted in the affiliated hospital of qinghai university .patients in the department of critical care medicine and emergency intensive care unit will be eligible for inclusion if they meet the berlin criteria.two researchers assess pulmonary artery pressure and right heart function of patients who are enrolled.


Eligibility criteria:
inclusion criteria: inclusion criteria: 18 to 80 years of age meet the diagnostic criteria receive invasive mechanical ventilation within 48 hours - exclusion criteria: patients with those disease will be excluded ： chronic obstructive pulmonary disease pulmonary embolism chronic heart failure idiopathic pulmonary fibrosis pulmonary hypertension pregnant women will be excluded too. -
phase 1b trial of bgj398/byl719 in solid tumors

Conditions: Advanced Solid Tumors; Metastatic Solid Tumors

Summary: to study the safety and efficacy of the combination of bgj398 with byl719 in patients whose tumors express mutations to pik3ca with or without alterations to fgfr 1-3.

this dose escalation/dose expansion study will evaluate the combination of orally administered bgj398 in combination with orally administered byl719. during the dose escalation part, the mtd of the combination will be determined in patients whose advanced or metastatic tumors express mutations to pik3ca. once the mtd has been determined, the expansion part will begin. patients will be addd to one of three arms based on the disease type and genetic changes. patients with metastatic colorectal cancer are not eligible for participation in the expansion part.

Eligibility criteria:
inclusion criteria: * histologically/cytologically confirmed advanced or metastatic solid tumors who have failed standard therapy or for whom no effective standard anti-cancer therapy exists * documented pik3ca mutations in all patients in dose escalation and expansion with or without documented genetic alterations in fgfr depending upon dose expansion cohort (either local or central determination) * measurable disease defined by recist v1.1 * ecog performance status of ≤2 exclusion criteria: * prior pi3ki or selective fgfr inhibitor treatment (for patients enrolled to expansion part) * colorectal cancer (for patients enrolled to expansion part) * patients with diabetes mellitus requiring insulin treatment and/or with clinical signs or with fasting glucose ≥ 140 mg/dl / 7.8 mmol/l, history of clinically significant gestational diabetes mellitus or documented steroid-induced diabetes mellitus * use of medications that increase serum levels of phosphorus and/or calcium * inorganic phosphorus outside of normal limits * total and ionized serum calcium outside of normal limits

Keywords: bgj398 byl719 advanced solid tumor metastatic breast cancer pk3ca fgfr fibroblast growth factor receptor
a ccta imaging trial to evaluate the effect of obicetrapib/ezetimibe on coronary plaque

Conditions: Lipidemia; Coronary Artery Disease; Plaque, Atherosclerotic

Summary: this placebo-controlled, double-blind, randomized, phase 3 study is being conducted in adult participants with high-risk atherosclerotic cardiovascular disease (ascvd) who are not adequately controlled by their maximally tolerated lipid-modifying therapy, to assess the impact of the obicetrapib 10 mg + ezetimibe 10 mg fdc daily on coronary plaque and inflammation characteristics, evaluated using cardiovascular computed tomography angiography (ccta).


Eligibility criteria:
inclusion criteria: * fasting serum ldl-c ≥70 mg/dl (≥1.81 mmol/l) * evaluable non-calcified plaque of at least 75 mm3 in the major epicardial coronary arteries * bmi 18-40, inclusive * max tolerated lipid modifying therapy * estimated glomerular filtration rate ≥40 ml/min/1.73 m2 exclusion criteria: * hba1c ≥10.0% (≥0.100 hemoglobin fraction) or a fasting glucose ≥270 mg/dl (≥15.0 mmol/l) at screening * contraindications for ccta * history of coronary artery bypass graft * active liver disease
the efficacy of velcade on bone tissue during myelomatosis (bone marrow cancer)

Conditions: Multiple Myeloma

Summary: the primary objective of the the study is to investigate the changes in bone remodeling during velcade treatment.

20 patients will be included in the study over a 2 year period. before, during and after treatment we will measure ntx-i, ctx-i, ctx-mmp, balp, dkk-1, pinp, tracp and pth. ntx, ctx and ctx-mmp are measured to estimate bone degradation. tracp is measured to estimate the activity of the osteoclasts. balp and dkk-1 is measured to evaluate the activity of the osteoblasts and pinp is measured as a marker of new bone formation. pth is measured in order to evaluate if the positive effects that is observed in bone formation in relations to velcade treatment is due to the pulsative way velcade is administered. the effect of the velcade treatment will be evaluated by x-ray, bone marrow and m-component.

Eligibility criteria:
inclusion criteria: * previously untreated multiple myeloma exclusion criteria: * use of bisfosfonates
etec logistics trial (trek)

Conditions: Diarrhea

Summary: this is a multicenter, double-blind, randomized, placebo-controlled field trial to evaluate the epidemiology of natural infection with etec occurring after transcutaneous immunization in a field setting.

the primary objectives of the study are to evaluate the incidence of etec illness in a field setting and to compare the safety of lt delivered by tci with placebo. the secondary objectives include, but are not limited to: evaluate the stool frequency per episode of etec illness in placebo recipients, to evaluate the immunogenicity of lt delivered by tci, to evaluate the incidence of ibs following travel to areas of etec endemnicity, and to evaluate the incidence of vpo in placebo and lt patch recipients.

Eligibility criteria:
inclusion criteria: * healthy adult men and women 18-64 years of age inclusive at screening * signed informed consent form * planned travel to an area within 2 ½ hours traveling distance of cuernavaca or guadalajara, mexico or antigua, guatemala (minimum stay of 7 days) * if female who is not post-menopausal or surgically sterile, negative pregnancy test (within 24 hours prior to vaccination) and agreement to employ an effective form of birth control or practice abstinence through the end of the study. exclusion criteria: * clinically significant abnormalities as determined by the investigator/clinician during physical inspection * received investigational product from 30 days before date of first vaccination or during the entire study period * ever received lt, etec, or cholera vaccine * history of traveler's diarrhea within the previous year * travel to a developing country within the last year * women who are pregnant or breastfeeding * history of achlorhydria * evidence of immunosuppression, including concomitant immunosuppressive therapy; fever \> 99.5°f (37.5°c) on day of vaccination * current problems with alcohol or substance abuse * an employee of the study clinic * sensitivity or allergy to any of the vaccine components * history of significant blood loss, blood product donation, or blood product recipient in the previous 60 days * planned use of imodium or antibiotics for self treatment of diarrhea during the study period * visible tattoos or marks (tattoos/scars) at the vaccination areas that would prevent appropriate dermatologic monitoring of the vaccination sites; and * medical history of acute or chronic gi illness or major gi surgery.

Keywords: etec traveler's diarrhea tci patch vaccine diarrhea prevention epidemiology etec escherichia coli